Activists Urge FDA, Congress To Approve Experimental Prostate Cancer Vaccine
About 100 activists -- led by Thomas Farrington, founder of the Prostate Health Education Network, which is primarily aimed at black men and others at high risk of the disease -- on Tuesday attended a rally in Washington, D.C., to urge FDA to approve an experimental prostate cancer vaccine, the Philadelphia Inquirer reports. Blacks are 50% more likely than whites to be diagnosed with and twice as likely to die from the disease.
The vaccine, Dendreon's Provenge, is in the last phase of clinical trials, according to the Inquirer. Provenge is currently undergoing a 500-patient study to prove its effectiveness. The vaccine works after cancer develops and provokes a "heightened immune [system] attack," the Inquirer reports. Such vaccines must first be tested only on patients who have exhausted all other treatment options, "even though such patients don't have much immune function left to boost," according to the Inquirer. In a small study, those taking Provenge had a median survival of 26 months, 4.5 months longer than for those who received a placebo.
Although an FDA advisory panel recommended the vaccine be approved and said it is safe and effective, FDA last month requested additional proof of its efficacy. Such an investigation "could add years more to Provenge's long development odyssey," according to the Inquirer.
Farrington, who testified before the Provenge advisory committee, said FDA has failed to support blacks. "If there was a mortality rate in white men as high as that of African-Americans, there would be a push to approve Provenge," he said (McCullough, Philadelphia Inquirer, 6/5).
